Biologics Tech Transfer Lead — Scale-Up & Validation

Alexion Pharmaceuticals, Inc.

Dublin

On-site

EUR 150,000 - 190,000

Full time

9 days ago

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Job summary

Alexion Pharmaceuticals, Inc. in Dublin seeks an Associate Director-level Technology Transfer Lead to own end-to-end transfers of bulk drug substance processes, ensuring validation readiness and compliant execution.

You will partner across Process Development, Operations, Engineering, QA, and Regulatory to deliver right-first-time transfers and shorten timelines to PPQ completion. The role requires 10+ years in tech transfer within biologics, strong cGMP knowledge, and leadership in a matrix

Qualifications

10+ years in Technical Services / Technology Transfer within a biological bulk drug substance manufacturing setting.
Experience leading a Technology Transfer program across multiple unit operations.
Strong knowledge of cGMP requirements for biopharma manufacturing.
Proven ability to lead matrix teams and communicate effectively.
Experience with digital tools or AI-enabled approaches to reduce transfer timelines.

Responsibilities

Lead end-to-end technology transfers of bulk drug substance processes to ensure validation readiness and PPQ completion.
Define validation strategies, author validation docs, guide PPQ activities to meet milestones.
Own process documentation, gap assessments, protocols and reports for robust execution.
Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times.
Collaborate with Process Development, Operations, Eng, QA, and Regulatory to ensure right-first-time transfers.
Provide hands-on support on scale-up and transfer decisions during plant studies and validation batches.